Gastric retaining devices and methods

Abstract

Methods, devices and systems facilitate gastric retention of a variety of therapeutic devices. devices generally include a support portion for preventing the device from passing through the pyloric valve or esophagus wherein a retaining member may optionally be included on the distal end of the positioning member for further maintaining a position of the device in the stomach. Some embodiments are deliverable into the stomach through the esophagus, either by swallowing or through a delivery tube or catheter. Some embodiments are fully reversible. Some embodiments self-expand within the stomach, while others are inflated or otherwise expanded.

We claim: 
     
       1. An apparatus for facilitating gastric retention, comprising:
 a positioning member having a shape adapted to pass at least partially through the pylorus of a patient, wherein the positioning member comprises a distal end, a proximal end, and a pyloric spanning segment in between the distal end and the proximal end, 
 an outer flexible member coupled to the proximal end of the positioning member, wherein the outer flexible member comprises a tissue contact surface, and the outer flexible member is invertible from a low-profile delivery configuration to an extended deployment configuration,
 wherein the tissue contact surface radially surrounds a portion of the pyloric spanning segment when the outer flexible member is in the delivery configuration, 
 wherein the outer flexible member is extended proximal to the proximal end of the positioning member when inverted into the deployment configuration, 
 wherein the pyloric spanning segment is uncovered by the outer flexible member and the pyloric spanning segment is open to the environment of the pylorus when the outer flexible member is inverted into the deployment configuration; 
 
 a core member coupled to the proximal end of the positioning member, wherein the outer flexible member in its deployment configuration at least partially surrounds the core member and the portion of the core member partially surrounded by the outer flexible member is configured to remain open to an environment of the stomach; and 
 a retaining member coupled to a distal end of the positioning member for maintaining the apparatus in intermittent contact with the pylorus. 
 
     
     
       2. The apparatus of claim wherein the deployment configuration is sized to intermittently obstruct the pylorus. 
     
     
       3. The apparatus of  claim 1  wherein the outer flexible member is invertible from the low-profile delivery configuration to the extended deployment configuration via inverting the tissue contact surface. 
     
     
       4. The apparatus of  claim 1  wherein the outer flexible member comprises a support portion in between the tissue contact surface and the core member. 
     
     
       5. The apparatus of  claim 1  wherein the core member comprises a proximal end and a distal end, wherein the distal end of the core member is coupled to the proximal end of the positioning member, and wherein a cross-sectional diameter of the core member orthogonal to a longitudinal axis of the apparatus is larger at the proximal end of the core member than the distal end of the core member. 
     
     
       6. The apparatus of  claim 1  wherein the tissue contact surface is comprised of a compliant material for atraumatic presentation against the stomach. 
     
     
       7. The apparatus of  claim 1  wherein the outer flexible member is reconfigurable via a shape memory material. 
     
     
       8. The apparatus of  claim 1  wherein the outer flexible member is reconfigurable via a spring-loaded material. 
     
     
       9. The apparatus of  claim 1 , wherein the positioning member is stationary relative to the core member and the retaining member when the outer flexible member inverts from the delivery configuration to the deployment configuration. 
     
     
       10. The apparatus of  claim 1 , wherein the positioning member is an extension of the core member. 
     
     
       11. The apparatus of  claim 1 , wherein the outer flexible member in the deployment configuration is sized to prevent or inhibit passage through a pylorus of the stomach. 
     
     
       12. The apparatus of  claim 1 , wherein the retaining member has an atraumatic shape. 
     
     
       13. The apparatus of  claim 1 , wherein the retaining member has a cross-sectional diameter larger than the cross-sectional diameter of the positioning member. 
     
     
       14. The apparatus of  claim 1 , wherein the location of the positioning member along the longitudinal access of the apparatus relative to the core member remains the same when the outer flexible member is in the delivery configuration and when the outer flexible member is in the deployment configuration.